Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus
Recruitment status was Recruiting
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Purpose
Systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD) are long-term autoimmune diseases in which the immune system attacks parts of the body. The abnormal immune reaction causes inflammation of and damage to various body parts and can affect joints, skin, kidneys, heart, lungs, blood vessels, and the brain. SLE and MCTD often affect young women, especially black and Hispanic women, and there is no known cure. Knowing more about SLE and MCTD will help in developing new and effective treatments. The purpose of this study is to characterize immune system abnormalities, genetic components, and disease progression in people with SLE and MCTD.
| Condition |
|---|
|
Mixed Connective Tissue Disease Systemic Lupus Erythematosus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Immune Response to Small Nuclear Ribonucleoprotein Autoantigens |
- Data characterizing CD4 T cells and corresponding clinical data [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- Phenotype measurement to include disease activity, disease severity, and functional status [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood cell DNA
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Systemic lupus erythematosus (SLE) is an autoimmune disease in which the immune system produces antibodies against the body's healthy cells and tissues. These antibodies, called autoantibodies, contribute to the inflammation of various parts of the body and can cause damage to organs and tissues. Mixed connective tissue disease (MCTD) is another autoimmune disease that overlaps in terms of signs and symptoms with three other connective tissue diseases, including SLE. In both SLE and MCTD, the immune system appears to be abnormally activated by small nuclear ribonucleoprotein (snRNP) autoantigens. Furthermore, lung tissue, in particular, appears to be affected by the immune response induced by snRNP autoantigens. The causes of SLE and MCTD remain unknown. However, it is likely that a combination of genetic, environmental, and possibly hormonal factors work together to cause the diseases. Past studies suggest that several different genes may be involved in determining a person's likelihood of developing SLE or MCTD, which tissues and organs are affected, and the severity of the disease. The purpose of this study is to characterize immune system abnormalities, genetic components, and disease progression in people with SLE and MCTD.
Participants will attend at least four study visits, spaced 3 months apart, over the course of this study. Each study visit will include questionnaires, a physical exam, and possibly blood and/or urine collection. At the end of the study period, participants may choose to continue or discontinue participation.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with MCTD and SLE
Inclusion Criteria:
- Presence of anti-RNP or anti-Sm antibodies
Exclusion Criteria:
- Lacking at least two criteria for MCTD or two criteria for SLE after the 1-year follow-up visit
Contacts and Locations| Contact: Judith Pignac-Kobinger, MS | 305-243-8567 | jpignac@med.miami.edu |
| Contact: Robert W. Hoffman, DO | 305-243-6866 | rhoffman@med.miami.edu |
| United States, Florida | |
| University of Miami Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33101 | |
| Contact: Judith Pignac-Kobinger, MS 305-243-8567 Jpignac@med.miami.edu | |
| Principal Investigator: | Robert W. Hoffman, DO | University of Miami |
More Information
No publications provided
| Responsible Party: | Robert W. Hoffman, University of Miami Miller School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00582881 History of Changes |
| Other Study ID Numbers: | R01 AR043308, 2R01 AR 043308-12A1 |
| Study First Received: | December 19, 2007 |
| Last Updated: | March 31, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
Anti-RNP/Sm Autoantibody-Positive MCTD SLE |
Additional relevant MeSH terms:
|
Connective Tissue Diseases Lupus Erythematosus, Systemic Mixed Connective Tissue Disease Disease Progression |
Autoimmune Diseases Immune System Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013